Long Acting Phosphodiesterase 5 Inhibitors as Add-on Therapy for Patients With Pulmonary Hypertension Treated With Prostanoids.

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Pulmonary arterial hypertension is a chronic disease of the lung blood vessels resulting in constriction and high pressures. Treatment is given with a variety of drugs including the prostanoid class (e.g. epoprostenol, iloprost and the phosphodiesterase 5 (PDE-5) inhibitors (e.g. sildenafil).

Although these drugs are known to be effective alone, little is known about combining them together in various combinations.

In this trial we will add a long-acting PDE-5 inhibitor to the treatment of patients with pulmonary arterial hypertension who currently are receiving only a prostanoid drug.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rabin Medical Center
• Treatments: Phosphodiesterase 5 Inhibitors; Tadalafil; Vardenafil Dihydrochloride

Criteria

Inclusion Criteria:

• All patients must satisfy current diagnostic criteria for pulmonary artery hypertension based on their historical right heart catheter data (within 3 years of study enrollment): Mean PAP >25mmHg at rest or >30mmHg with exercise, by a PCWP< 15mmHg and by PVR >3 Wood Units.

• Currently stable for at least 3 months on prostanoid monotherapy (epoprostenol iv or iloprost inhaled).

• Willing and able to participate in all study follow-up procedures.

• New York Heart Association (NYHA) Class II-IV.

• Six minute walking distance between 100-450 meters at the baseline assessment.

• Women of child-bearing age must demonstrate adequate contraception or undergo a pregnancy test.

• Patients with congenital heart disease are eligible for inclusion.

Exclusion Criteria:

• Functional Class NYHA Class I.

• PAH due to chronic pulmonary thromboembolic disease, left heart disease, chronic lung diseases (VC or FEV1 < 60% of predicted) or chronic hypoxia.

• Acute intercurrent illness requiring hospital admission in the month proceeding screening.

• Any non-PAH medical condition likely to interfere with participation in evaluation of study endpoints, e.g. musculoskeletal disorders.

• Any uncontrolled or terminal non-PAH medical condition likely to interfere with completion of the study, according to the judgment of the study physician.

• Concomitant therapy with drugs known to interact adversely with the study drug.

• Chronic renal failure - creatinine clearance <50ml/min as calculated with the Cockcroft equation.

• Current participation in another clinical trial.

• Pregnancy or planned pregnancy during the study period.